Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial

Sandra L. Spoelstra, PhD, RN,1 Charles W. Given, PhD,2 Alla Sikorskii, PhD,3 Constantinos K. Coursaris, PhD,4 Atreyee Majumder, PhDc, BS,3 Tracy DeKoekkoek, RN,1 Monica Schueller, BA,1 and Barbara A. Given, PhD, RN, FAAN1 1

College of Nursing, Michigan State University, East Lansing, Michigan. Departments of 2Family Medicine, 3Statistics and Probability, and 4 Telecommunication, Information Studies, and Media, Michigan State University, East Lansing, Michigan. This study has been presented in part at the m-Health Summit: Healthcare at Your Fingertips, held in Washington, D.C., in December 2013, at the Oncology Nursing Society Annual Research Conference—Connections: Advancing Care Through Science, held in Dallas, Texas, November 2013, and at the Greater Lansing Area Research Day, Sigma Theta Tau, Michigan State University/McLaren Cancer Institute, held in Lansing, Michigan, in March 2013.

Abstract Introduction: This multisite, randomized controlled trial assigned 75 adult cancer patients prescribed an oral anticancer agent to either an experimental group that received daily text messages for adherence for 21 days plus usual care or a control group that received usual care. Materials and Methods: Measures were administered at baseline, weekly (Weeks 1–8), and at exit (Week 9). A satisfaction survey was conducted following the intervention. Acceptability, feasibility, and satisfaction were examined. Primary outcomes were adherence and symptoms. Secondary outcomes were depressive symptoms, self-efficacy, cognition, physical function, and social support. Mixed or general linear models were used for the analyses comparing trial groups. Effect sizes (ES) were estimated to gauge clinical significance. Results: Regarding acceptability, 57.2% (83 of 145) of eligible patients consented, 88% (n = 37 of 42) receiving text messages read them most or all of the time, and 90% (n = 38) were satisfied. The differences between experimental and control groups’ ES were 0.29 for adherence, 0.21 for symptom severity, and 0.21 for symptom interference, and differences were not statistically significant. Furthermore, perceived social support was higher (p = 0.04;

DOI: 10.1089/tmj.2015.0126

ES = 0.54) in the experimental group. Conclusions: Proof of concept and preliminary efficacy of a mobile health intervention using text messages to promote adherence for patients prescribed oral anticancer agents were demonstrated. Patients accepted and had high satisfaction with the intervention, and adherence improved after the intervention. Text messages show promise. Additional research is needed prior to use in practice. Key words: behavioral health, mobile health, technology, teleoncology

Introduction

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ith more than 50 oral anticancer agents (OAs) on the market, it is projected that within the next decade, 25% of cancer treatment will be in pill form.1 Recent reviews on OAs indicate adherence rates are often less than 80%.2,3 OAs often come with side effects, which in turn may lead to adverse events and nonadherence.3 OA treatment requires patients to self-manage side effects from treatment and adherence in the home setting.4 Most cancer patients are older and also have comorbid conditions and take multiple medications, which likely make symptoms more severe, as well as adherence more difficult.5 Other known factors that may influence adherence include medication frequency and complexity, adverse effects of the medication, forgetfulness, beliefs about importance of taking the medication, or inability to pay.6 The available evidence suggests self-management of OAs is a significant clinical problem that may impact treatment success or failure.7,8 Cell phones have been widely adopted and are rapidly evolving as a cost-effective mode of delivering tailored behavioral interventions.9,10 There are more than 285 million cell phone subscribers in the United States,11 and it is estimated 81% of users send and receive text messages (TMs).12 Evidence is beginning to show that TMs built on Social Cognitive Theory13 increase self-efficacy and improve health outcomes.14 TMs have also improved medication adherence in multiple diseases,6 with one trial finding more correct medication doses taken on time.15

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Materials and Methods

PROCEDURES After consents to participate were obtained, baseline interviews (Week 0) were conducted by phone. An automated voice response system was used to complete weekly assessments (Weeks 1–8) of OA adherence and 19 commonly experienced symptoms. Satisfaction surveys were conducted at the completion of the TMs (Week 4) by phone. Exit interviews were conducted by phone at the end of the study (Week 9). Medical records were audited at the end of the study to gather data on the prescribed dosages of OAs, dose changes, and stoppages.

STUDY DESIGN This study used a multisite, longitudinal (10-week), randomized controlled trial design with two groups: the experimental group with 21 days of short message service TMs for adherence plus usual care and a control group with usual care (2:1 allocation ratio). Assessments occurred at baseline before random assignment, weekly, and at exit. The satisfaction survey occurred immediately after TMs ended. The protocol was approved by the institutional review boards at each site and was published previously.16

RANDOM ASSIGNMENT AND BLINDING After baseline data were collected, participants were randomly assigned using a 2:1 ratio of experimental to control condition using a minimization algorithm, designed by the biostatistician in SAS version 9.4 software (SAS Institute, Cary, NC). The minimization balanced the groups on age (

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial.

This multisite, randomized controlled trial assigned 75 adult cancer patients prescribed an oral anticancer agent to either an experimental group that...
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